MedTrace Logo

Allogeneic Micronized Amniotic Membrane Product for the Treatment of Hidradenitis Suppurativa

NCT04541550 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2021-09-08

No results posted yet for this study

Summary

This study is an open-label, dose-escalation study enrolling 15 participants.

There are 3 cohorts:

1. Cohort I: 5 subjects each receiving 1 injection of IGN-AMP001 (12.5mg AMP-001 in 3ml Saline)
2. Cohort II: 5 subjects each receiving 1 injection of IGN-AMP001 (25 mg AMP-001 in 3 ml Saline)
3. Cohort III: 5 subjects each receiving 1 injection of IGN-AMP001 (50 mg AMP-001 in 3 ml Saline).

Conditions

Interventions

DRUG

AMP-001 Low Dose

AMP-001, is manufactured from the amniotic membrane of the placenta and does not contain living cells.

DRUG

AMP-001 Medium Dose

AMP-001, is manufactured from the amniotic membrane of the placenta and does not contain living cells.

DRUG

AMP-001 High Dose

AMP-001, is manufactured from the amniotic membrane of the placenta and does not contain living cells.

Sponsors & Collaborators

  • IntegoGen, LLC

    lead INDUSTRY

Principal Investigators

  • Stephen Mahoney, MD · West Houston Dermatology Laser and Skin Care Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2021-07-01
Completion
2021-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04541550 on ClinicalTrials.gov